RFQ 13417 TJRV Retrospective Epidemiological Study - packet.pdf

REQUEST FOR QUOTES (RFQ) 13417

PUBLIC HEALTH SERVICES

TIJUANA RIVER VALLEY CHEMICAL POLLUTION IMPACT INVESTIGATION:

RETROSPECTIVE EPIDEMIOLOGICAL STUDY

October 2, 2026

A. KEY INFORMATION

1. The County of San Diego is seeking quotes from firms interested in providing Tijuana River Valley Chemical Pollution Impact Investigation: Retrospective Epidemiology Study (“Offerors”).

2. The County anticipates a contract term of an initial (base) period of fifteen (15) months.

3. The County has posted this solicitation on its official BuyNet website at https://sdbuynet.sandiegocounty.gov/.

To see all information related to this RFQ, to submit Questions, and to receive notifications of updates, Offerors must select “Participate in RFx” for this solicitation in BuyNet.

4. The Contracting Officer for this solicitation is Julie Terrell, Procurement Contracting Officer, julie.terrell@sdcounty.ca.gov

5. The County estimates the cost of services as $200,000 to $250,000 for the full contract term.

6. Schedule: This timeline is subject to change at any time, at the County’s sole discretion. The County will issue an addendum for changes to the Questions due date, or Quote due date.

Event Description Date and Time (San Diego Time) Questions due October 9, 2026 prior to 5:00 p.m.

Quotes due October 30, 2026 prior to 5:00 p.m.

7. Questions:

7.1. Offerors should submit all Questions, including requests for clarification related to definition or interpretation of this RFQ, in writing by the Date and Time specified in the Schedule. Offerors should submit Questions via BuyNet, by sending a message to the Contracting Officer through the “Discussions” functionality.

7.2. Non-Offerors should direct inquiries regarding this solicitation to the Contracting Officer.

8. Table of Contents:

A. Key Information B. RFQ Instructions and Rules C. Submittal Items D. Required Forms E. Statement of Work F. Payment Schedule G. Draft Agreement

MAGGIE RAMSBERGER

INTERIM DIRECTOR

DEPARTMENT OF PURCHASING AND CONTRACTING

5560 OVERLAND AVENUE, SUITE 270, SAN DIEGO, CALIFORNIA 92123-1204

PHONE (858) 505-6367 FAX (858) 715-6452

BRENDA G. MILLER

ASSISTANT DIRECTOR

https://sdbuynet.sandiegocounty.gov/ mailto:julie.terrell@sdcounty.ca.gov

COUNTY OF SAN DIEGO – REQUEST FOR QUOTATIONS (RFQ) 13417

TIJUANA RIVER VALLEY CHEMICAL POLLUTION IMPACT INVESTIGATION:

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B. RFQ INSTRUCTIONS AND RULES

1. INSTRUCTIONS FOR SUBMITTING A QUOTE

1.1. It is Offeror’s responsibility to submit a quote based on the most current RFQ, addenda thereto, County’s responses to Questions, any other information posted on BuyNet, and any diligence material made available by the County. Offerors are advised to regularly check BuyNet for information. The County has no obligation to contact Offerors directly with any such RFQ-related information.

1.1.1. To see all information related to this RFQ, to submit Questions, and to receive notifications of updates, Offerors must select “Participate in RFx” for this solicitation in BuyNet.

1.1.2. If an Offeror is unable to download this document, an Offeror may request a hard copy from

Department of Purchasing and Contracting’s front desk or contact clerical support at (858) 505- 6367.

1.2. Forms required to be submitted with Offerors response to this RFQ are included in this RFQ or posted on the County’s web site at: https://www.sandiegocounty.gov/content/sdc/purchasing/purchasing-forms.html.

1.2.1. The County may update posted forms from time to time. Unless otherwise specified, Offerors may submit the version of a form in place as of the date of the posting of this RFQ or any later version thereof.

1.3. Offeror must submit a complete original quote in accordance with the format provided in this solicitation to the County of San Diego, Department of Purchasing and Contracting, through electronic upload to BuyNet before the Date and Time listed in Schedule.

1.3.1. If Offeror is unable to submit via BuyNet for any reason, Offeror may submit its quote via email to the Contracting Officer listed in this document or provide the Purchasing and Contracting front desk with either (i) electronic files on CD/DVD; or, (ii) a printed quote. Offeror must prominently mark such submissions with the RFQ number on the outside of the packaging. Please use this method only if unable to submit through BuyNet.

2. QUESTIONS

2.1. Offerors shall direct requests for explanation regarding the RFQ or related documents to the Contracting

Officer, in writing, as a question (“Question”). Offerors may submit Questions by sending a message to the Contracting Officer through the “Discussions” functionality in BuyNet.

2.2. The County may choose not to respond to Questions received after the date and time stated in the Schedule for Question submission. Offeror is responsible for ensuring that Questions are received by the County.

3. QUOTE FORMAT

3.1. Submit electronic quotes as files in .pdf format, except where specified otherwise. For pages other than signature pages, converted and searchable formats are preferred.

3.2. All quotes shall be signed with a handwritten signature by an authorized officer or employee of Offeror.

4. QUOTE ORGANIZATION

4.1. Your quote should be organized in accordance with the Submittal Items in this RFQ.

4.1.1. Offerors shall organize content to correspond to the applicable exhibit and question or item within each exhibit.

4.1.2. Offerors shall separate each exhibit into one or more files, clearly named as to the exhibit and order.

4.1.3. Pages shall be consecutively numbered within each exhibit at the bottom or top margin of each page.

4.1.4. Cost/Price information:

4.1.4.1. Offerors must place all cost and pricing information within the Cost/Price exhibit. Price shall be inclusive of all proposed compensation.

4.2. Confidential/Proprietary information:

https://www.sandiegocounty.gov/content/sdc/purchasing/purchasing-forms.html https://www.sandiegocounty.gov/content/sdc/purchasing/purchasing-forms.html

TIJUANA RIVER VALLEY CHEMICAL POLLUTION IMPACT INVESTIGATION:

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4.2.1. The County is a public agency subject to the California Public Records Act, Government Code § 7920.000, et seq. Some or all of the documents submitted in response to this RFQ may be subject to disclosure, and the County intends to publish any resulting contracts to its public website.

4.2.2. It is Offeror’s responsibility to identify and separate into a “CONFIDENTIAL/PROPRIETARY” exhibit and to provide a signed Nondisclosure Indemnification Agreement for:

4.2.2.1. All confidential information that Offeror represents, with legal basis, is exempt from disclosure pursuant to the California Public Records Act, including PI (Personal Information), PII (Personally Identifiable Information), or PHI (Protected Health Information);

4.2.2.2. Any proprietary or other information Offeror represents, with legal basis, is exempt from disclosure under the California Public Records Act and wishes to protect from disclosure.

4.2.3. The “CONFIDENTIAL/PROPRIETARY” exhibit must be clearly labeled with all pages marked as “CONFIDENTIAL/PROPRIETARY.”

4.2.4. Offeror should reference material in the “CONFIDENTIAL/PROPRIETARY” exhibit where it is needed to respond to a Submittal Item through citation to the “CONFIDENTIAL/PROPRIETARY” exhibit (for example “See response 1 contained within the ‘CONFIDENTIAL/PROPRIETARY’ exhibit for staff Social Security numbers”).

4.2.5. If the County determines that a submission improperly designates information as confidential or proprietary, the County may, at its sole discretion: (i) deem the information releasable; (ii) declare the submission non-conforming/non-responsive; (iii) remove such information, or (iv) take any other appropriate action. (Note: Pricing and Terms and Conditions are generally not confidential under the California Public Records Act).

5. QUOTE EVALUATION

5.1. Evaluations may consider factors such as technical merit, experience, capacity, history of Offeror compliance, availability, price, and more to determine the quote(s) that provide the best value to the County.

5.2. During evaluation, the County may appropriately consider the sustainability and social, human health, environmental, and economic impact of Offeror’s proposed products and/or approach to providing goods and/or services, in accordance with Board Policy B-67. Therefore, Offerors are encouraged to include relevant information in their quotes, to the degree related to the goods or services sought.

5.3. During evaluation, the County may appropriately evaluate the cultural competency of Offeror and Offeror’s proposed approach to providing goods and services. Therefore, Offerors are encouraged to include relevant information in their quotes, to the degree related to the goods or services sought.

5.4. When evaluating an Offeror’s cost or pricing, the County may also consider the effect of the quote on the overall total cost to the County.

5.5. Reserved.

6. COUNTY COMMITMENT

6.1. This RFQ does not commit the County to award a contract, nor does it commit the County to pay any of

Offeror’s costs incurred in the preparation or submission of the quote. Further, Offeror shall not incur any reimbursable cost in anticipation of a contract award.

6.2. Neither Offeror nor any of its representatives shall have any claims whatsoever against the County or any of its respective officials, agents, or employees arising out of or relating to this RFQ or these procedures (other than those arising under a definitive contract with Offeror in accordance with the terms thereof).

6.3. The County reserves the right to separately procure the same or similar goods or services.

6.4. The County may withhold all information regarding this procurement until after negotiations are complete, including, but not limited to: the number of quotes received; the identity of Offeror(s); the content of quotes; the County’s evaluation and results thereof. Information releasable after the conclusion of

TIJUANA RIVER VALLEY CHEMICAL POLLUTION IMPACT INVESTIGATION:

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negotiations is subject to the disclosure requirements and withholding exemptions of the California Public Records Act.

6.5. Pursuant to County Charter §§ 703.10 and 916, award of a contract resulting from this RFQ may be subject to the County’s requirement to determine that the services can be provided more economically and efficiently by an independent contractor than by persons employed in the Classified Service.

6.6. In the event that an Offeror is involved in a merger, acquisition, or other change in control, the County reserves the right to award a contract to a resulting entity.

7. DILIGENCE AND DUTY TO INQUIRE

7.1. Should Offeror find discrepancies in or omissions from, or be in doubt as to the meaning of, the RFQ or related documents, Offeror shall have a duty to submit a Question to the County.

7.2. Offerors are expected to perform reasonable due diligence with regard to this RFQ and the work required, including, but not limited to, information that is publicly or otherwise reasonably available and, if applicable, information that can be obtained during a site visit (including verification of measurements, conditions, and other attributes). Neither the selected Offeror(s), nor any Offerors, shall be entitled to any price adjustment or other relief based upon information that was discovered or should have been discovered through due diligence.

7.3. The County makes no representation or warranty, express or implied, as to the accuracy or completeness of any diligence material or other information provided by the County or any of its agents, representatives, contractors, or consultants. Such information may reflect good faith assumptions, estimates, or projections, which may or may not prove to be correct.

7.4. Offeror should not rely upon oral statements made or explanations given by the County, including any oral responses to Questions or other inquiries. No prior, current, or post award communication(s) with any officer, agent, or employee of the County shall affect or modify any terms or requirements of this RFQ, except as explicitly provided for in this RFQ.

8. OFFEROR COMMUNICATIONS

8.1. All communications from Offeror (including its employees, agents, and representatives) to the County or its officers and employees (including consultants working on or assisting with this procurement), related to this RFQ or Offeror’s quote, must be directed in writing exclusively to the Contracting Officer, unless otherwise authorized in writing by the Contracting Officer. Offerors shall not communicate with or attempt to contact any other County personnel about this solicitation, except as otherwise allowed for in this RFQ or by law. Any improper contact may, at the County’s sole discretion, cause Offeror to be removed from consideration for contract award.

8.2. If Offeror issues any public announcement or otherwise engages in communication that, in the County’s sole determination, compromises the integrity of this RFQ process or attempts to restrain competition, Offeror may be removed from consideration for award.

8.3. Audio and/or video recording of presentations, discussions, negotiations, , or other communications with the County regarding this RFQ are prohibited, unless specifically authorized in writing by the Contracting Officer.

9. SOLICITING EMPLOYEES

9.1. Until contract award, Offerors shall not, directly or indirectly, solicit any employee of the County to leave the County’s employ in order to accept employment with Offeror, its affiliates, actual or prospective contractors, or any person acting in concert with Offeror without prior written approval of the County’s Contracting Officer. This paragraph does not prevent the employment by Offeror of a County employee who has initiated contact with Offeror.

10. PROHIBITED CONTRACTS AND SUBCONTRACTS

10.1. In accordance with Section 67 of the San Diego County Administrative Code, the County shall not contract with, and shall reject any quote submitted by, the person or entities specified below, unless the Board of Supervisors finds that special circumstances exist which justify the approval of such contract:

TIJUANA RIVER VALLEY CHEMICAL POLLUTION IMPACT INVESTIGATION:

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10.1.1. Persons employed by the County or of public agencies for which the Board of Supervisors is the governing body;

10.1.2. Profit-making firms or businesses in which employees described in subsection 11.1.1 serve as officers, principals, partners, or major shareholders;

10.1.3. Persons who, within the immediately preceding twelve (12) months, came within the provisions of subsection 11.1.1 and who (i) were employed in positions of substantial responsibility in the area of service to be performed by the contract; or, (ii) participated in any way in developing the contract or its service specifications; and

10.1.4. Profit-making firms or businesses in which the former employees described in subsection 11.1.3 serve as officers, principals, partners, or major shareholders.

10.2. Per Board Policy A-79, a successful Offeror that is a non-profit corporation shall not subcontract any work under the agreement with a related for-profit subcontractor where an interlocking directorate, management, or ownership relationship exists, unless specifically authorized by the Board of Supervisors.

10.3. Offeror certifies that, if awarded a contract under this RFQ, such contract will be in compliance with Sections 11.1 and 11.2 above. Offeror shall promptly notify the County of any change in circumstance affecting these provisions.

11. CALIFORNIA REVENUE & TAXATION CODE § 18662

11.1. In compliance with California Revenue and Taxation Code § 18662, if Offeror is a non-resident of

California (out-of-state invoices) that receives California source income and has not completed Franchise Tax Board Form 590, there may be a backup withholding on all payments. Fifteen (15) business days prior to the first payment from the County, new suppliers or suppliers with expired forms or forms with incorrect information must submit new forms to the County (forms are available from the Franchise Tax Board website listed below).

11.2. Under certain circumstances, Offerors may be eligible for reduced or waived nonresident withholding. If Offeror has already received a waiver or a reduced withholding response from the State of California and the response remains valid, Offeror should submit the response to the County in lieu of the forms. Failure to submit the required forms will result in withholding of payments. Offerors should access the Franchise Tax Board websites, listed below, for tax forms and relevant information regarding non-resident withholding, including waivers or reductions. The County will not give Offerors any tax advice. It is recommended that Offerors speak with their tax advisers and/or the State of California for guidance.

Franchise Tax Board Websites:

https://www.ftb.ca.gov https://www.ftb.ca.gov/forms/search/

11.3. If selected for award, Offeror must submit applicable forms to the Auditor & Controller via fax, at (858) 694-2060, or mail originals to: County of San Diego, 5530 Overland Avenue, Suite 410, San Diego, CA 92123. The P.O. Number or Contract Number (if available) and “California Revenue and Taxation Code § 18662” must appear on fax cover sheet and/or the outside of the mailing envelope.

12. W-9 FORM

12.1. If selected for award, Offeror must complete and submit a W-9 form if a current form is not on file with the County.

13. PREVAILING WAGE

13.1. Reserved.

https://www.ftb.ca.gov/ https://www.ftb.ca.gov/forms/search/

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C. SUBMITTAL ITEMS

Offeror’s narrative response to these Submittal Requirements shall be no more than fifteen (15) pages, excluding supporting materials submitted as attachments. Attachments are for additional documentation to support the narrative and are not to be used to extend the narrative beyond the page limitation. When including attachments, reference the specific supporting information in the applicable portion(s) of your narrative response. The County has no obligation to read beyond the maximum page limit when evaluating the proposals, nor to review or search attachments for relevant information.

1. EXHIBIT 1 - REQUIRED FORMS

1.1 Submit a completed and signed Offeror’s Cover Page (PC600) form

• Required for all Offerors

• located at:

https://www.sandiegocounty.gov/content/dam/sdc/purchasing/docs/PC600_dpc_Offerors_Cover_Page.pdf

1.2 Submit a completed and signed Representations and Certifications form (PC601)

• Required for all Offerors

• located at:

https://www.sandiegocounty.gov/content/dam/sdc/purchasing/docs/PC601_dpc_Reps_and_Certs.pdf

1.3 Submit a completed and signed Small-Local Business Self-Certification Form (PC610)

• All Offerors are encouraged to complete this form to support County data collection.

• located at:

https://www.sandiegocounty.gov/content/dam/sdc/purchasing/docs/PC610_dpc_Small_Local_Self_Cert.pdf

1.4 Submit a completed and signed Nondisclosure Indemnification Agreement (PC620) (if applicable).

• Required if submitting Confidential/Proprietary Information (see RFQ Instructions and Rules section 4.2)

• located at:

https://www.sandiegocounty.gov/content/dam/sdc/purchasing/docs/PC620_dpc_Nondisclosure_Indemnity.pdf

2. EXHIBIT 2 - PROGRAM/TECHNICAL EXHIBIT

2.1 Provide responses to the following:

2.1.1 Describe how the Offeror will design, implement, and conduct a Retrospective Epidemiological Study component of the County of San Diego’s Tijuana River Valley Chemical Pollution Impact Investigation to assess whether there is evidence for health effects due to past exposures to the emissions from the Tijuana River Valley. The Offeror may use various sources of data, including but not necessarily limited to de-identified hospital discharge data, cancer registry data, mortality data, and Census data. This study will seek to identify any exposure-response relationships across areas of generally different exposure, as defined by the Exposure Characterization Study currently underway (relevant results will be shared as applicable and as needed throughout the course of this project).

2.1.1.1 Provide an action plan to conduct the Retrospective Epidemiological Study. The action plan should include start and completion dates, required strategies employed, responsibilities (persons, organizations, and agencies), dependencies (actions which must be completed before subsequent actions may be initiated or completed), and milestones (significant actions and dates). Insert milestones dates on the Payment Schedule.

2.1.2 Confirm (YES/NO) that Offeror has relevant experience in designing, implementing, and conducting retrospective epidemiological studies.

YES NO

https://www.sandiegocounty.gov/content/dam/sdc/purchasing/docs/PC600_dpc_Offerors_Cover_Page.pdf https://www.sandiegocounty.gov/content/dam/sdc/purchasing/docs/PC601_dpc_Reps_and_Certs.pdf https://www.sandiegocounty.gov/content/dam/sdc/purchasing/docs/PC610_dpc_Small_Local_Self_Cert.pdf https://www.sandiegocounty.gov/content/dam/sdc/purchasing/docs/PC620_dpc_Nondisclosure_Indemnity.pdf

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2.1.2.1 If yes, please describe prior experience in designing, implementing, and conducting retrospective epidemiological studies.

2.1.3 Confirm (YES/NO) that Offeror can meet specific requirements in the Statement of Work.

YES NO

2.1.3.1 If yes, please describe how Offeror will meet requirements in the Statement of Work.

2.1.4 Provide a list of de-identified data the Offeror proposes to obtain and use. Contractor shall use, but not necessarily be limited to, mortality data, cancer registry data, hospital discharge data, and Census data.

2.1.4.1 Provide a narrative describing why this list was selected; describe the process to obtain the data; and what experience the Offeror has with the data organizations.

2.1.5 Confirm (YES/NO) that Offeror has experience in obtaining Health Insurance Portability and Accountability (HIPAA) data, Institutional Review Board (IRB) approvals, Data Use Agreements (DUAs), and other data access, privacy, and compliance documentation.

YES NO

2.1.5.1 If yes, please provide a narrative describing such experience.

2.1.6 Confirm (YES/NO) that Offeror has experience in developing and implementing Quality Assurance/Quality Control plans.

YES NO

2.1.6.1 If yes, please provide a narrative describing such experience.

2.1.7 Confirm (YES/NO) that Offeror has experience with risk mitigation plans addressing issues such as registry delays or potential data gaps.

YES NO

2.1.7.1 If yes, please provide a narrative describing such experience and how the Offeror proposes to implement a risk mitigation plan.

2.1.8 Confirm (YES/NO) that Offeror has experience in providing analytical workflow tools and procedures for ensuring reproducibility, including documentation practices.

YES NO

2.1.8.1 If yes, please provide a narrative describing such experience.

2.1.9 Confirm (YES/NO) that Offeror has experience working in communities identified as Environmental Justice (EJ) Communities.

YES NO

2.1.9.1 If yes, please provide a narrative describing such experience.

2.1.10 Confirm (YES/NO) that Offeror has experience conducting studies in communities impacted by chemical pollution similar to communities in proximity to the Tijuana River Valley.

YES NO

2.1.10.1 If yes, please provide a narrative describing such experience.

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2.1.10.2 If no, please describe similar experience demonstrating the ability to work with these communities.

2.1.11 Provide brief resume for the lead scientist overseeing the Retrospective Epidemiological Study and other key people involved in the project. Include:

2.1.11.1 Role

2.1.11.2 Tasks

2.1.11.3 Relevant qualifications

2.1.11.4 Data handling responsibilities

2.1.11.5 Security compliance procedures

2.1.12 Provide two (2) business references for whom your organization has provided services of a scope similar to the County requirements. Detail:

2.1.12.1 Customer/Agency

2.1.12.2 Dates of services provided

2.1.12.3 Contact Name, Position

2.1.12.4 Contact Business Email / Business telephone number

2.1.12.5 Short description of the work/project

3. EXHIBIT 3 - COST/PRICE EXHIBIT

3.1 Submit a completed Payment Schedule

3.1.1 Offeror to propose number of Data Use Agreements (minimum of three should be established to gather mortality data, cancer registry data, hospital discharge data, Offeror may propose more as appropriate).

3.1.2 Offeror to propose milestones completion dates.

3.2 Confirm (YES/NO) that Offeror understands that prices are firm fixed for the term of this contract and cannot be increased at any time. In addition, please confirm that Offeror understands this is the only compensation offeror will receive for work performed, and shall be all inclusive over any overhead costs, or items not itemized in the Payment Schedule.

YES NO

4. EXHIBIT 4 – ACCEPTANCE OF TERMS AND CONDITIONS

4.1 Confirm acceptance “YES/NO” of the County of San Diego’s Draft Agreement (including insurance requirements):

YES ☐ NO ☐

4.1.1 If “NO,” provide a detailed list of exceptions to the terms and conditions, the nature of its concern, and what terms the Offeror is willing to accept.

Note: The Offeror will be deemed to have accepted any terms and conditions of the Contract to which it does not take exception to. The County may, as part of its evaluation process, conclude that exceptions are so numerous and/or material as to make Offeror’s response to the solicitation unacceptable.

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5. EXHIBIT 5 – CONFIDENTIAL PROPRIETARY

5.1 Include any Confidential/Proprietary Information in this exhibit, in accordance with RFQ Instructions and Rules section 4.2

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D. REQUIRED FORMS

(RESERVED)

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E. STATEMENT OF WORK

1. Scope of Work/Purpose

1.1. The Contractor shall design, implement, and conduct a Retrospective Epidemiological Study (Retrospective Study) component of the County of San Diego’s Tijuana River Valley (TJRV) Chemical Pollution Impact Investigation. The purpose of this study is to assess whether there is evidence for health effects due to past exposures to the emissions from the Tijuana River Valley. The contractor may use various sources of data, including but not necessarily limited to de-identified hospital discharge data, cancer registry data, mortality data, and Census data. This study will seek to identify any exposure-response relationships across areas of generally different exposure, as defined by the Exposure Characterization Study currently underway (relevant results will be shared as applicable and as needed throughout the course of this project).

In addition to learning more about potential health impacts associated with the TJRV sewage and pollution crisis, the County of San Diego intends to use the results of the Retrospective Epidemiological Study to inform a potential future Long-term Health Panel Study.

2. Background Information

2.1. The Tijuana River flows from Mexico into California, traversing the Tijuana River Valley and discharging into the Pacific Ocean near Imperial Beach. The river carries untreated sewage, industrial waste, and other contaminants that produce strong odors-often described as a “rotten eggs” smell- and cause significant community concern, most immediately in the city of Imperial Beach, and Nestor and San Ysidro neighborhoods of the City of San Diego. In fact, since 2023 the County has locally proclaimed the Tijuana River Valley sewage issue to be an emergency.

As part of the response to these ongoing environmental conditions, the County is undertaking a Retrospective Epidemiological Study to obtain a comprehensive evaluation of historical pollutant exposures and the correlation with community health outcomes, as well as identifying spatial and temporal exposure patterns to understand at a broader level the effects on health of the chemical pollutants associated with the Tijuana River Valley.

2.2. Community Health Concerns

A 2024 Community Assessment for Public Health Response (CASPER) by the Centers for Disease Control and Prevention (CDC) and the County of San Diego Public Health Services found that 70% of surveyed households reported health problems they attributed to the Tijuana River pollution. Reported health issues include headaches, nausea, upset stomach, cough, irritated throat, and various other symptoms. These findings were corroborated by the Assessment of Chemical Exposures (ACE) survey conducted by the County and the Agency for Toxic Substances and Disease Registry (ATSDR).

The reported concerns underscore the need for a comprehensive evaluation of historical pollutant levels and exposure events. To the extent that the data permits, the Retrospective Epidemiological Study is intended to conduct a comprehensive evaluation, explore potential correlations with community health concerns and identify spatial and temporal exposure patterns.

2.3. Chemical Emissions

A “hot spot” in the Tijuana River Valley near where Saturn Boulevard crosses the Tijuana River in the city of San Diego is identified as a primary source of airborne chemical emissions, including hydrogen sulfide (H2S) and other potential pollutants.

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Utilizing the identified chemical emissions from the Exposure Study (Contract #575592) will allow this study to correlate localized environmental exposure data with historical cancer registry, mortality data, and hospital discharge data.

2.4. Overall Project

The County may use the data obtained from the Retrospective Study to inform the potential subsequent Long-Term Health Panel Study (prospective health assessment), subject to the availability of funding.

2.5. Environmental Justice Considerations

Communities located in proximity to the Tijuana River Valley include populations that have been identified through federal health assessments as experiencing disproportionate environmental burdens and social vulnerabilities. These communities may face cumulative impacts related to environmental exposures, limited access to resources, and historical inequities.

In conducting the Retrospective Study, the County will evaluate how historical inequities and cumulative environmental exposures correlate with patterns in the mortality data, cancer registry, and hospital discharge data.

2.6. A Trauma-Informed System: The County of San Diego Health and Human Services Agency (HHSA) is committed to becoming a Trauma-Informed System as part of its effort to build a better service delivery system. All programs operated and supported by HHSA shall be part of a Trauma-Informed System, which includes providing trauma-informed services and maintaining a trauma-informed workforce. It is an approach for engaging individuals – staff, clients, partners, and the community – and recognizing that trauma and chronic stress influence coping strategies and behavior. Trauma-informed systems and services minimize the risk of re-traumatizing individuals and/or families and promote safety, self-care, and resiliency.

Trauma-Informed Principles include:

• Understanding trauma and its impact to individuals;

• Promoting safety;

• Awareness of cultural, historical, disability, and gender issues, and ensuring competence and responsiveness;

• Supporting consumer empowerment, control, choice, and independence;

• Sharing power and governance (e.g. including clients and staff at all levels in the development and review of policies and procedures);

• Demonstrating trustworthiness and transparency;

• Integrating services along the continuum of care;

• Believing that establishing safe, authentic, and positive relationships can be healing;

• Understanding that wellness is possible for everyone

2.7. Live Well San Diego Vision: HHSA supports the Live Well San Diego vision of Building Better Health, Living Safely, and Thriving. Live Well San Diego, developed by the County of San Diego, is a comprehensive, innovative regional vision that combines the efforts of partners inside and outside County government to help all residents be healthy, safe, and thriving. All HHSA partners and contractors, to the extent feasible, are expected to advance this vision. Building Better Health focuses on improving the health of residents and supporting healthy choices. Living Safely seeks to ensure residents are protected from crime and abuse, neighborhoods are safe, and communities are resilient to disasters and emergencies.

Thriving focuses on promoting a region in which residents can enjoy the highest quality of life. Information about Live Well San Diego can be found on its website dedicated to the vision:

http://www.LiveWellSD.org http://www.livewellsd.org/

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This project supports the Live Well San Diego vision of Building Better Health, Living Safely, and Thriving by identifying and mitigating environmental exposures affecting regional communities. Requirements, deliverables, and measurable outcomes in Statement of Work that support Live Well San Diego may be found in the following sections: 3.1 through 3.2.5.

3. Goals and Outcomes

All goals and objectives below are amounts which the Contractor is required to meet each contract year. If the contract year is less than 12 months, annual amounts will be prorated.

3.1. Goals: The primary goals of the Retrospective Study are to analyze de-identified health and mortality data and evaluate whether there are statistical associations suggesting that communities exposed to emissions from the Tijuana River Valley exhibited elevated rates or patterns of diagnosed health outcomes and to assess whether those outcomes show exposure-related gradients consistent with modeled past environmental exposure levels.

3.1.1. Contractor shall evaluate whether past diagnosed health outcomes occurred at elevated rates and in an exposure-related pattern as defined by the Exposure Characterization Study within communities exposed to emissions from the Tijuana River Valley.

3.1.2. Contractor shall incorporate appropriate demographic and socioeconomic covariates to reduce confounding where feasible.

3.1.3. Contractor shall use, but not necessarily be limited to, mortality data, cancer registry data, hospital discharge data, and Census data to examine rates of diagnosed conditions identifiable within these datasets, as well as temporal trends and geographic patterns in those rates.

3.1.4. Contractor shall identify diagnosed health outcomes of potential concern that may be further examined in a future Long-term Health Panel Study.

3.2. Outcome Objectives: Contractor shall achieve the following Outcome Objectives:

3.2.1. Contractor shall define geographic exposure zones (at least “high”, “medium” and “low”) based on the Exposure Characterization Study and, using Census data, assign populations to these zones for analysis.

3.2.2. Contractor shall obtain and link existing hospital discharge data, cancer registry data, and mortality data records to the defined exposure areas.

3.2.3. Using the Census-derived population data Contractor shall calculate historical rates of outcome-specific hospitalizations, cancers, and mortality within each defined exposure zone over the period being investigated.

3.2.4. Contractor shall compare health outcomes rates and evaluate temporal trends and whether health outcomes differ in an exposure-related pattern between “high”, “medium”, and “low” exposure areas.

3.2.5. Contractor shall use appropriate statistical methods to determine whether differences in health outcomes are likely due to chance and to identify any patterns where conditions occurred more frequently than expected.

3.2.6. Contractor shall identify uncertainties and potential biases that limit interpretation of results.

4. Focus Population and Geographic Area

4.1. Focus Population: Contractor shall evaluate health outcomes for individuals in San Diego County across various exposure areas.

TIJUANA RIVER VALLEY CHEMICAL POLLUTION IMPACT INVESTIGATION:

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5. Definitions

5.1. TJRV: Tijuana River Valley

5.2. ACE: Assessment of Chemical Exposures

5.3. CASPER: Community Assessment for Public Health Emergency Response

5.4. ATSDR: Agency for Toxic Substances and Disease Registry

5.5. H2S: Hydrogen Sulfide

5.6. IRB: Institutional Review Board

5.7. HIPAA: Health Insurance Portability and Accountability Act

5.8. PHI: Protected Health Information

5.9. DUAs: Data Use Agreements

5.10. CCR: California Cancer Registry

6. General Requirements for Service Delivery

6.1. Contractor shall ensure all work is performed by qualified staff with appropriate expertise in clinical data management, biostatistics and epidemiology.

6.2. The Contractor shall not subcontract any portion of the work under this Agreement without prior written approval from the County.

6.2.1. The Contractor shall disclose to the County all proposed subcontractors, including:

6.2.1.1. the specific tasks to be assigned;

6.2.1.2. subcontractor qualifications;

6.2.1.3. the names and roles of key personnel;

6.2.1.4. whether subcontractors will access or handle HIPAA-regulated or sensitive data.

6.2.2. The Contractor shall remain fully responsible for the performance, conduct, security compliance, and deliverables of all subcontractors. Approval of a subcontractor does not relieve the Contractor of any contractual obligations.

6.3. Contractor shall coordinate closely with County staff and designated technical advisors to align study parameters, milestones, and deliverables.

6.4. Contractor shall ensure that all reports and materials meet accessibility standards (plain-language executive summary, visual aids for community presentation).

6.5. Contractor shall provide quarterly updates and participate in progress meetings as requested by the County.

6.6. All media, materials, publications, presentations, press releases, promotional materials for media events, logos, and any other products developed under this contract shall be submitted to the County for review and approval prior to dissemination. All materials shall follow the current County brand guidelines and logo guidelines provided by the County.

6.7. All data generated from this contract is owned by the County of San Diego.

6.8. Contractor shall request and obtain approval from the County prior to:

TIJUANA RIVER VALLEY CHEMICAL POLLUTION IMPACT INVESTIGATION:

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6.8.1. Sharing any preliminary, draft, or in-progress findings, data interpretations, or analytical outputs generated under this Scope of Work with any third parties. No results, whether preliminary or final, shall be released, presented, or disseminated in any form until the County has reviewed all deliverables and provided written approval for public release or distribution.

6.8.2. Utilizing any data generated by this contract in any work outside the scope of this contract.

7. Specific Requirements for Service Delivery

7.1. Retrospective Study:

7.1.1. Contractor shall identify, obtain, and maintain the agreements necessary to access all data sources required. All agreements must support the study’s analytical needs to comply with applicable confidentiality, data-sharing, and security requirements.

7.1.2. Contractor shall propose an appropriate look‑back period for each dataset and provide justification based on statistical power, disease latency, data completeness, and methodological best practices.

Look-back period should be at least 10 years, unless otherwise justified.

7.1.3. Contractor shall link health data with mapped exposure zones. Use existing mortality data, cancer registry data, hospital discharge data, and Census data to examine health conditions.

7.1.4. Contractor shall use findings to identify patterns or clusters of health concerns to be further studied in a potential Long-term Health Panel Study.

7.1.5. Contractor shall utilize the exposure zones, modeled exposure estimates, and geospatial outputs developed under the Exposure Characterization Study when assigning exposures for this Retrospective Study and shall ensure methodological consistency to support the potential Long‑term Health Panel Study.

7.1.5.1. Contractor shall document the geospatial and exposure‑mapping methods applied, including geocoding procedures, spatial resolution, assumptions, and uncertainty considerations.

7.1.6. Contractor shall geocode all records to the highest resolution permitted by each dataset and shall report geocoding completeness, resolution levels achieved, unmatched records, and methods used to address incomplete or indeterminate address data.

7.1.7. Contractor shall document all statistical methods, including model assumptions, confounder selection, exposure response criteria, and sensitivity analyses.

7.1.8. Contractor shall conduct sensitivity analyses to the extent that the data permits.

7.2. Project Team Qualifications

7.2.1. Contractor shall have experience in accessing, cleaning, and analyzing mortality, California Cancer Registry (CCR) and/or hospital discharge databases.

7.2.2. Contractor shall have experience in securing IRB approvals and handling HIPAA regulated PHI.

7.2.3. Contractor shall have documented capability to merge geographic environmental exposure models with localized patient-level records.

8. Data Collection

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8.1. Contractor shall submit a list of considered data sources, including but not necessarily limited to hospitals, cancer registries, and mortality records from which contractor will obtain health data, within 15 days of contract execution.

9. Deliverables and Regulatory Compliance

9.1. Contractor shall submit a draft Study Protocol, including a statistical analysis plan, within thirty (30) days of contract execution for County’s review and input.

9.2. Contractor shall submit the final Study Protocol responding to the County’s comments and edits within fifteen (15) days of receiving County’s feedback.

9.2.1. Contractor shall document in the Draft and Final Report all deviations from the approved Final Study Protocol that are made during the course of the study.

9.3. Contractor shall provide confirmation to the County of Data Use Agreements (DUA) submission for each registry or database required for the Retrospective Study (a minimum of 3 DUAs should be established to gather mortality data, cancer registry data, hospital discharge data, Offeror may propose more as appropriate).

9.3.1. Contractor shall provide the County with executed copies of each DUA within five (5) business days of receiving the executed agreement.

9.3.2. Contractor shall notify the County of registry delays affecting data access timelines.

9.4. Contractor shall be solely responsible for preparing, submitting, and obtaining all necessary approvals from an accredited Institutional Review Board (IRB).

9.4.1. Contractor shall submit to the County a copy of IRB approval letter and any associated contingencies within five (5) business days of receipt.

9.4.2. Contractor shall maintain active IRB approval throughout the entire contract period.

9.5. Contractor shall meet HIPAA and California state confidentiality laws.

9.5.1. Contractor shall provide the County with a copy of the Data Security and Privacy Plan used to protect all data accessed for the Retrospective Study within thirty (30) business days of contract execution.

9.5.1.1. Contractor shall notify the County of any updates to this Plan during the contract period.

10. Reporting Requirements

10.1. Progress Reports:

10.1.1. Contractor shall submit quarterly progress reports on the work conducted for the study on a template to be agreed upon by both County and the Contractor.

10.2. Final Deliverables:

10.2.1. Contractor shall submit a draft final report to the County for review that includes:

10.2.1.1. the study methods, an outline of the data obtained, data analysis results, discussion and interpretation of the results, and conclusions, including recommendations for follow-up investigation by two (2) months before the end of the contract.

10.2.2. Contractor shall incorporate the County’s feedback into the final report to be submitted one (1) month before the end of the contract.

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10.2.3. In addition to the final report, Contractor shall submit:

10.2.3.1. “Clean” datasets for each of the data sources used in the investigation.

10.2.3.2. Data dictionaries for the datasets.

10.2.3.3. Presentation materials for County leadership and community briefings.

10.2.4. Contractor shall submit a Completeness Assessment Summary documenting:

10.2.4.1. Completeness by variable

10.2.4.2. Completeness by exposure zone

10.2.4.3. Justification for any analytic exclusions

11. Validation and Data Management

11.1. Contractor shall develop and submit a Quality Assurance/Quality Control (QA/QC) plan to ensure accuracy, logical consistency, and scientific validity of the linked epidemiological dataset within one hundred and twenty (120) days of contract execution.

11.2. Contractor shall outline the linkage algorithms, temporal logic rules, coding crosswalks, and missing data protocols.

11.3. Contractor shall maintain QA/QC protocols consistent with HIPPA and IRB standards.

11.4. Contractor shall provide the final processed data in County-approved formats (e.g., CSV, shapefile). All data provided shall be complete, final, and ready for County use without additional processing.

11.5. Contractor shall provide sufficient documentation, training, and technical support to enable the County to understand the data.

12. Performance Acceptance Criteria

12.1. Statistical Analysis Standards

12.1.1. Contractor shall document all statistical methods, including model assumptions, confounder selection, exposure response criteria, and sensitivity analyses.

13. Community Engagement

13.1. Contractor shall collaborate with the County to share information, updates, and answer questions at community and stakeholder meetings as requested by the County.

14. Contractor Responsibilities and Acceptance Criteria

14.1. Timely completion of deliverables per contract schedule.

14.2. Timely submission of complete IRB approvals as soon as possible and ideally within 90 days of contract execution.

14.3. Timely submission of signed Data Use Agreements (DUAs) with the registries and databases that will be utilized.

14.4. Timely submission of documented HIPAA compliant data management and encryption plan prior to receiving any mortality data, cancer registry data, hospital discharge data, and Census datasets.

14.5. Quality and Completeness of Data and Deliverables. Performance will be measured based on compliance with the acceptance criteria outlined in Section 11 (Validation and Data Management).

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14.5.1. Providing complete documentation, metadata, scripts, and codebooks ready for County use without additional processing.

14.5.2. Providing statistically valid and well‑documented analyses.

14.6. Contractor shall ensure accuracy and scientific validity of analyses by using:

14.6.1. Appropriate analytic methods

14.6.2. Correct application of exposure-response modeling

14.6.3. Identification of uncertainties and biases

14.6.4. Execution of sensitivity analyses (as applicable)

14.6.5. Clarity and accessibility of findings for stakeholders.

TIJUANA RIVER VALLEY CHEMICAL POLLUTION IMPACT INVESTIGATION:

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F. PAYMENT SCHEDULE

1 COMPENSATION

1.1 Payment for services described in the Statement of Work, will be on a fixed price basis and occur after the County reviews and accepts the original monthly invoice in accordance with this Payment Schedule.

1.2 Contractor shall be compensated based on rates in Payment Schedule for services authorized by the County. The fixed rate prices are “fully loaded” rates to include all Contractor’s indirect and direct costs to provide the services. Costs in addition to the fixed fee shall not be invoiced.

2 PAYMENTS

2.1 In accordance with Article 4, Compensation, of the Agreement, all requests for payments are subject to County review and acceptance of deliverables and submitted documentation at the time of invoice. Pending any adjustments by the Contracting Officer’s Representative (COR) or designee, each invoice approved and paid shall constitute full and complete compensation to the Contractor for the invoice.

3 INVOICES

3.1 Contractor shall submit uniquely numbered invoices with original signatures to the County by the 10th calendar day after the end of the Reporting month. Invoices are due the next business day if the due date falls on a weekend or holiday.

3.2 With each invoice submission, Contractor shall ensure the following:

3.2.1 Invoice has original signature or scanned, in PDF format, submitted via email and original kept by Contractor

3.2.2 Include the Excel spreadsheet version of the invoice template provided by the COR or designee

3.2.3 Invoice contains a unique invoice number generated by Contractor

3.2.4 Invoice has authorized signatory’s signature

3.3 County will provide an invoice template and requirements for completion

3.4 Invoices shall be submitted to the:

Contracting Officer’s Representative (COR) or Designee.

TIJUANA RIVER VALLEY CHEMICAL POLLUTION IMPACT INVESTIGATION:

CONTRACT TERM

DATE SIGNED – XX/XX/2028

Milestones Statement of Work Section

Milestone Description (Task) Proposed Milestone

Completion (from Action Plan)

Unit of Measure

Estimated number of units

Unit Price

1 9.1 Draft Study…